What we do
Physical chemical properties and analytical methods department
Our team of experts brings many years of experience in different regulatory authorities and from the industry and covers all European zones with the different nationalities.
On the basis of a 5-batch analysis, we draw up legally compliant specifications of their active substances for our customers. This exact description is just as important for the establishment of a new production source for the European market as for the planned participation in a task force, which is regularly organised and accompanied by the GAB.
It does not matter whether the active substance is a chemical single substance, a natural or synthetic mixture of substances or a microorganism.
We can support you in the preparation of the corresponding parts of a registration dossier for new registrations or re-registrations of an active substance or a product and check the already existing physicochemical and analytical data for completeness. The performance of necessary GLP or non-GLP studies to complete your data set is reliably organised by us and accompanied during the performance. Depending on your wishes or requirements, we can prepare the summaries of the studies in Word or IUCLID format.
We have been working with reliable and first-class laboratories for years, both for the physico-chemical and the necessary pre- and post-registration analytical methods, in order to guarantee our customers a problem-free process.
Our team of experts includes EUROTOX-certified toxicologist and approved university teachers in toxicology.
We can support you in:
- Critical evaluation of available toxicological data (both chemicals and microorganisms)
- Identifying which studies are required (based on regulatory data requirements)
- Commission, design, monitor, summarize and interpret all types of toxicological studies according to relevant guidelines (in vitro, acute toxicity, repeated dose, reproductive toxicity; dermal absorption, genotoxicity, endocrine disruption)
- avoiding studies, if possible (non-testing methods – QSAR or read across; science-based waivers and expert statements)
- Classification and labelling according to Regulation (EU) 1272/2008 and relevant ECHA-guidance
- Compiling full dossiers for active substances and/or products
Using the latest relevant exposure models following guidance and our experience we estimate the non-dietary exposure of operators, workers, bystanders, residents and the general public.
If needed, for higher tier refinement, we also design, commission and monitor field studies (DFR, DT50, Operator-, worker- or bystander exposure)
Based on hazard assessment and exposure estimation a risk assessment is performed including risk management proposals.
Our team of experts combines a broad experience of study performance and their regulatory assessment. We highly profit from our direct contact to field services and our long-term experience with regulatory authorities.
We can support you with:
- Data gap analyses and advice on study requirements;
- Planning, commissioning, monitoring and evaluating studies investigating the nature or magnitude of residues in plants, plant commodities or livestock;
- The preparation of your residues dossiers for active substance approvals and product authorisations;
- Consumer risk assessments following EU and national models for pesticides;
- Exposure calculations for biocides;
- MRL applications;
- Scientific support with negotiations with authorities in pre-submission meetings or dossier defence activities;
- Expert statements
Our environmental fate team consists of competent and highly motivated experts with collective decades of experience in dossier preparation and exposure / risk assessment. We can support you in:
- Data gap analyses including preliminary exposure and risk assessment
- Dossier strategy and preparation for active substance approval and product registration
- Expert statements (e.g. authority responses, justifying risk mitigation measures, defense of existing studies, or waive study requirements)
Exposure and risk assessment
- Exposure and risk assessment for standard (e.g. agricultural field) and non-standard applications (e.g. non-professional use, greenhouse applications, fogging, post-harvest use, paddy field) including scenario development
- Environmental modelling following registration requirements at EU and Zonal/MS level
- Higher tier modelling (e.g. SWAN, VFSMOD, GeoPEARL, FROGS, customised exposure scenarios)
- Design and supervision of laboratory and field studies investigating the metabolism, degradation/dissipation or mobility of active substances or metabolites in all compartments
- Higher tier studies (e.g. soil dissipation studies, guideline adaptations) including investigations of complex mixtures
- Proficient in current and draft guidance (e.g. OECD, US-EPA, SETAC)
Data evaluation and preparation
- Evaluation of laboratory and field studies (standard and higher tier)
- Kinetic (re)evaluation following FOCUS kinetics
- Normalisation of DegT50field values to reference conditions
- Evalulation according to POP, PBT and vPvB criteria
- Extensive experience with plant extracts, oily substances, inorganic substances and complex mixtures (e.g. UVCB) used as active substance
- Internal QA by senior experts
- Active participation in conferences and workshops
- Knowledge management at all levels
- Long-term contact with national authorities
Our multinational experts bring to the ecotoxicological team many years of very diverse experience from different fields such as contract research organisations or evaluating regulatory Authorities.
Our team can provide you with regulatory support in all the necessary steps starting from completeness check and ending up with dossier defence. We are involved on a daily basis in:
- Detailed Data Gap Analysis including Preliminary Risk Assessments, including discussions on the strategy and evaluation of existing data
- Providing advices on the strategies for possible testing and ecotoxicological risk assessment
- Discussion and support in study designs, study monitoring and later study evaluation for standard and higher tier ecotoxicology studies
- Literature researches
- Meetings with Regulatory Authorities in different Member States
- Ecotoxicological risk assessments including different tailor-project specific higher tier refinement options during dossier preparation
- Assessments answering various Member State specific requirements
- Expert statements and opinions
- Ad-hoc requests for post submission support defending strategies at the dossier level
In addition we are also member of various expert working groups and participating in the update and elaboration of Guidance Documents.
Our team of experts combines a broad range of experience regarding the performance of efficacy as well as their regulatory assessment and presentation. We highly profit from our direct contact to field services and our long-term experience with requests from regulatory authorities.
- Scientific support on efficacy testing strategies: number and distribution of trials and their study design;
- Efficacy claim checks;
- Design, coordination and monitoring efficacy, selectivity or processing studies for (bio-)pesticides, biostimulants and biocides;
- Critical assessments of data packages and preparation of Biological Assessment Dossiers.
Our teams of project managers are long experienced regulatory scientists (agronomists, chemists, (micro-biologists) from different nationalities, with wide industry background and an average regulatory competence of 12 years.
Whatever your type of product is (agrochemicals, biopesticides, fertilizers & biostimulants, biocides), our project management team can support you in:
- Successful planning, preparation, submission, and defense of your products
- Defining a project tailored regulatory strategy for an optimized access to the market
- Developing a global picture combining the scientific aspects as well as the overall regulatory requirements
- Coordinating the communication with authorities, and contract institutes
- Knowing about the latest regulatory developments on European and national level, as well as global worldwide strategies
Our zonal experts support you with their onsite long-term experiences for national submissions in local language:
- Provision of zonal requirements
- Direct submission to national authorities.
GAB Consulting has the mission to assure a high level quality of projects
- Review full dossiers for active substances and/or products
- Assurance of the consistency within your dossier, the clarity and completeness based on regulatory and authorities’ data requirement
- Monitoring of quality activities during your project
- Development and continuous updating of relevant standard operating procedures (SOPs) for constructive cooperation at GAB
- Sanitisation of documents according to confidentiality requests and regulatory requirements.
Our Documentation group can support you in every kind of dossier organization and submission.
Organization of your studies in our internal database, in IUCLID and CADDY format:
- GAB internal database can manage all kind of dossier structures
- We follow the transparency regulation to respect all confidential claims
- Notify your studies on the EFSA portal
Submission of your dossiers according to actual requirements:
- We support you on additional authority requests and submission
- Organization and purchasing literature in compliance with copyright rules
- Exchange and correspondence with European and national authorities
We can support you for the planning, organization and monitoring of your projects and dossiers.
- Organization of all critical steps; data gap analysis, study conduction, dossier preparation, submission, dossier defense
- Monitoring adequate scientific workflow
- Flexible replanning in case of individual study delays or overall voting on project extension on European level
GAB Consulting is part of the SynTech Research Group. For more information visit www.syntechresearch.com